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San Francisco, California – Iovance Biotherapeutics, Inc. (Nasdaq: IOVA), a biotechnology company specializing in the treatment of cancer, announced that AMTAGVI™ (Lipileucel) has received FDA approval for patients with advanced melanoma. This is the first FDA-approved T-cell therapy for solid tumor cancer, providing a new treatment option for melanoma patients after initial treatment.
Amtagvi is designed for adult patients with unresectable or metastatic melanoma whose disease has progressed despite prior treatment with PD-1 blocking antibodies and, where applicable, targeted therapies. This treatment uses the patient’s own tumor-infiltrating lymphocytes (TILs), which are expanded and retransfused to fight the cancer.
The FDA’s accelerated approval was based on the overall response rate (ORR) and duration of response observed in the C-144-01 clinical trial. In this clinical trial, 31.5% of patients showed an objective response, many of which lasted more than 12 months. The results of this study were published in the journal Cancer Immunotherapy.
Frederick Vogt, Ph.D., interim CEO of Iovance, expressed the company’s commitment to expanding novel cell therapies for solid tumors. The approval of Amtagvi provides a one-time personalized treatment option for patients with advanced melanoma, addressing a critical unmet need.
Amtagvi will be administered at an Authorized Therapeutic Center (ATC), where more than 30 tumor tissues are processed and ready to be shipped for manufacturing. Manufacturing will be handled at the Iovance Cell Therapy Center (iCTC) in Philadelphia, a facility dedicated to the production of TIL cell therapies, with plans to expand manufacturing capacity in the future.
Iovance is also conducting TILVANCE-301, a confirmatory Phase 3 clinical trial for Amtagvi, and is investigating its application in other solid tumor types.
This article is based on a press release from Iovance Biotherapeutics.
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